Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery (PIVOTS-Rehab)

Pilot Investigation of Transauricular Vagal Nerve Stimulation Safety and Feasibility in Acute Incomplete Spinal Cord Injury Rehabilitation

This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI).

This study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility.

This study has two main goals:

1. To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury.
2. To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started.

This study has two parts.

In the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel.

In the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries (Complete and Incomplete)
• Intervention / Treatment: Device: Transauricular vagus nerve stimulation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Rachel E Cowan, PhD; Phone Number: 2059345034; Email: recowan@uabmc.edu
• Study Contact Backup: Name: Christopher Williamson, MBA; Phone Number: 2059343776; Email: cmwilliamson@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
      • Contact: Rachel E Cowan, PhD; Phone Number: 2059345034; Email: recowan@uabmc.edu
      • Contact: Rachel; Phone Number: 2059345034; Email: recowan@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Phase 1 Age 18 years older SCI (traumatic or non traumatic) undergoing initial inpatient rehabilitation for the SCI Any AIS severity level (A, B, C, D)
• Phase 2 Completed phase I Participant willing to complete phase II Study physician approves participation in phase II Receives intensive gait training as a part of the care plan

Exclusion Criteria:

• Phase 1 Age >89 years Pregnant Implanted medical device (e.g. pacemaker, cochlear implant) epilepsy Parkinson's Disease Multiple Sclerosis cerebral shunts documented arrhythmia Ear skin irritation or damage at the electrode contact location intracranial metal implants
• Phase 2 no exclusion criteria for those who meet inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: taVNS application; This is a single arm study with two Phases. In Phase 1 taVNS will be applied bilaterally for a brief period while the individual is in inpatient rehabilitation In Phase 2 taVNS will be applied for a brief period immediately before each mobility therapy session while the period is in inpatient rehabilitation. The mobility therapy sessions are routine care. Frequency and intensity of these sessions are determined by the therapists. All individuals must complete Phase 1 before starting Phase 2. Not all individuals who complete Phase 1 will be eligible for Phase 2. Please see eligibility criteria for more details.

Device: Transauricular vagus nerve stimulation; bilateral transauricular vagal nerve stimulation; Other Names: taVNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1 Hypotension Symptoms Immediately before taVNS is applied	Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible	Immediately before Phase 1 taVNS application
Phase 1 Hypotension Symptoms during taVNS spplication	Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible	During application of Phase 1 taVNS
Phase 1 Hypotension Symptoms Immediately after taVNS is stopped	Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible	Immediately after Phase 1 taVNS is stopped
Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped	Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible	5 minutes after Phase 1 taVNS is stopped
Phase 1 taVNS Tolerability survey	10 question survey addressing perceived sensation, tolerability, side effects, and open text response	Within 48 hours of competing Phase 1 taVNS
Phase 2 taVNS Tolerability survey	10 question survey addressing perceived sensation, tolerability, side effects, and open text response	Within 48 hours of completing Phase 2 taVNS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1 Blood Pressure Immediately before taVNS is applied	Systolic and Diastolic Blood Pressure (mmHg)	Immediately before taVNS Phase 1 application is applied
Phase 1 Blood Pressure during taVNS application	Systolic and Diastolic Blood Pressure (mmHg)	During taVNS Phase 1 application
Phase 1 Blood Pressure Immediately after taVNS is stopped	Systolic and Diastolic Blood Pressure (mmHg)	Immediately after taVNS Phase 1 application is stopped
Phase 1 Blood Pressure 5 minutes after taVNS is stopped	Systolic and Diastolic Blood Pressure (mmHg)	5 minutes after taVNS Phase 1 application is stopped
Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission	Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record	Admission to rehabilitation
Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge	Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record	Immediately after discharge from rehabilitation

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Rachel E Cowan, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; spinal cord injuries; walking; vagus nerve stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: IRB-300015896; UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is an internally funded study with limited personnel support. Adequate preparation of the data to ensure seamless and rigorous sharing cannot be guaranteed at the time of registration. The investigators may update the plan to share IPD in the future if additional personnel support becomes available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No